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Order of the Ministry of Environmental Protection
(No. 7)
The Measures for Environmental Management of New Chemical Substances, which were revised and adopted at the 3rd executive meeting of the Ministry of Environmental Protection on December 30, 2009, are hereby promulgated and shall come into force on October 15, 2010.
The Measures for Environmental Management of New Chemical Substances promulgated by the former State Environmental Protection Administration on September 12, 2003 shall be abolished simultaneously.
Minster of the Ministry of Environmental Protection Zhou Shengxian
January 19, 2010
Measures for Environmental Management of New Chemical Substances
| | 环境保护部令
（第7号）
《新化学物质环境管理办法》已由环境保护部2009年第三次部务会议于2009年12月30日修订通过。现将修订后的《新化学物质环境管理办法》公布，自2010年10月15日起施行。
2003年9月12日原国家环境保护总局发布的《新化学物质环境管理办法》同时废止。
环境保护部部长 周生贤
二○一○年一月十九日
新化学物质环境管理办法
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Chapter I General Provisions
| | 第一章 总则
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Chapter II Notification Procedures
| | 第二章 申报程序
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Chapter III Registration Management
| | 第三章 登记管理
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Chapter IV Follow-up Control
| | 第四章 跟踪控制
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Chapter V Legal Liabilities
| | 第五章 法律责任
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Chapter VI Supplementary Provisions
| | 第六章 附则
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Chapter I General Provisions
| | 第一章 总则
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Article 1 (Legislative Purpose) These Measures are formulated in accordance with the Decision of the State Council on Establishing Administrative Licenses for the Administrative Examination and Approval Items Really Necessary to Be Retained and other relevant laws and administrative regulations for purposes of controlling environmental risks of new chemical substances, guaranteeing human health, and protecting the ecological environment.
| | 第一条 【立法目的】为了控制新化学物质的环境风险，保障人体健康，保护生态环境，根据《国务院对确需保留的行政审批项目设定行政许可的决定》以及其他有关法律、行政法规，制定本办法。
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Article 2 (Scope of application) These Measures shall apply to the environmental management of the activities in relation to the research, production, import, processing and use of new chemical substances within the territory of the People's Republic of China. The environmental management of the activities in relation to new chemical substances in the bonded areas and export processing areas shall also be governed by these Measures.
The management of pharmaceuticals, pesticides, veterinary medicines, cosmetics, food, food addictive, feed addictive, etc. shall be governed by the relevant laws and regulations. However, the environmental management of the activities related to new chemical substances used as raw materials and intermediates of the aforesaid products shall be governed by these Measures.
The articles which are designed to intentionally release contained new chemical substances in their normal use shall be governed by these Measures.
| | 第二条 【适用范围】本办法适用于在中华人民共和国关境内从事研究、生产、进口和加工使用新化学物质活动的环境管理。保税区和出口加工区内的新化学物质相关活动的环境管理，也适用本办法。
医药、农药、兽药、化妆品、食品、食品添加剂、饲料添加剂等的管理，适用有关法律、法规；但作为上述产品的原料和中间体的新化学物质相关活动的环境管理，适用本办法。
设计为常规使用时有意释放出所含新化学物质的物品，按照本办法管理。
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Article 3 (Classification) New chemical substances shall be categorized into general new chemical substances and hazardous new chemical substances according to the standards for identification and classification of hazardous properties of chemicals.
Hazardous new chemical substances that are persistent, bio-accumulative, and hazardous to ecological environment or human physical health shall be classified as hazardous new chemical substances of priority environmental management.
The term “new chemical substances” as mentioned in these Measures refers to chemical substances that are not listed in the Inventory of Existing Chemical Substances in China.
The Inventory of Existing Chemical Substances in China is formulated, adjusted and published by the Ministry of Environmental Protection.
| | 第三条 【分类】根据化学品危害特性鉴别、分类标准，新化学物质分为一般类新化学物质、危险类新化学物质。
危险类新化学物质中具有持久性、生物蓄积性、生态环境和人体健康危害特性的化学物质，列为重点环境管理危险类新化学物质。
本办法所称新化学物质，是指未列入《中国现有化学物质名录》的化学物质。
《中国现有化学物质名录》由环境保护部制定、调整并公布。
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Article 4 (Basic System) The State shall conduct classified management of risks of new chemical substances, and implement the systems of notification and registration and follow-up control thereon.
| | 第四条 【基本制度】国家对新化学物质实行风险分类管理，实施申报登记和跟踪控制制度。
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Article 5 (Registration Certificate) A producer or importer of a new chemical substance must submit a notification of the new chemical substance and obtain the registration certificate for environmental management of the new chemical substance (hereinafter referred to as “registration certificate”) prior to production or import.
A new chemical substance without registration certificate shall be prohibited from being produced, imported, processed or used.
A new chemical substance without registration certificate or failed to be filed and notified shall be prohibited from being used for scientific research.
| | 第五条 【登记证】新化学物质的生产者或者进口者，必须在生产前或者进口前进行申报，领取新化学物质环境管理登记证（以下简称“登记证”）。
未取得登记证的新化学物质，禁止生产、进口和加工使用。
未取得登记证或者未备案申报的新化学物质，不得用于科学研究。
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Article 6 (Encouraging Advanced Technology) The State shall support the scientific research on the technologies of assessment and control of environmental and health risks from new chemical substances, promote advanced applicable technologies for controlling environmental risks of new chemical substances, support the research, production, import, processing and use of environment-friendly alternates to chemical substances, and encourage the notifiers to share notification and registration data of new chemical substances.
| | 第六条 【鼓励先进技术】国家支持新化学物质环境风险、健康风险评估和控制技术的科学研究，推广先进适用的新化学物质环境风险控制技术，鼓励环境友好型替代化学物质的研究、生产、进口和加工使用，鼓励申报人共享新化学物质申报登记数据。
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Article 7 (Confidentiality) The staff members engaged in environmental management of new chemical substances shall keep confidential the business secrets and technical secrets for the notifiers.
| | 第七条 【保守秘密】从事新化学物质环境管理的工作人员，应当为申报人保守商业秘密和技术秘密。
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Article 8 (Public Supervision) All entities and individuals are entitled to disclose, report and impeach the violations of these Measures.
| | 第八条 【公众监督】一切单位和个人都有权对违反本办法规定的行为进行揭发、检举和控告。
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Chapter II Notification Procedures
| | 第二章 申报程序
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Article 9 (Types of Notification) The notification of new chemical substances shall be classified into regular notification, simplified notification and scientific research filing notification.
| | 第九条 【申报类型】新化学物质申报，分为常规申报、简易申报和科学研究备案申报。
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Article 10 (Requirements for Regular Notification) Where the annual production or import volume of a new chemical substance is at or above one metric ton, the producer or importer shall submit a notification report on new chemical substances to the Chemical Registration Center of the Ministry of Environmental Protection (hereinafter referred to as “Registration Center”) prior to production and import for going through the regular notification; however, if it meets the conditions for simplified notification, simplified notification shall be gone through.
A notification report on new chemical substances shall include the following contents:
| | 第十条 【常规申报要求】新化学物质年生产量或者进口量1吨以上的，应当在生产或者进口前向环境保护部化学品登记中心（以下简称“登记中心”）提交新化学物质申报报告，办理常规申报；但是，符合简易申报条件的，可以办理简易申报。
新化学物质申报报告，应当包括下列内容：
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(1) A regular notification form for new chemical substances, attached with classification and labels and msds conducted according to the safety rules for classification, precautionary labeling and precautionary statements of chemicals and other relevant national standards;
| | （一）新化学物质常规申报表，并附具按照化学品分类、警示标签和警示性说明安全规范等国家有关标准进行的分类、标签和化学品安全技术说明书；
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(2) a risk assessment report, including hazard assessment of the notified substance, exposure scenarios assessment and risk control measures, assessment results of environment and health risks, etc.; and
| | （二）风险评估报告，包括申报物质危害评估、暴露预测评估和风险控制措施，以及环境风险和健康风险评估结论等内容；
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(3) a test report or materials of the substance's physicochemical properties and toxicological and eco-toxicological properties, and the eligibility testimonial of the relevant testing institutions. The eco-toxicological testing report must include the data of test conducted on a Chinese test species within the territory of China according to the relevant standards.
| | （三）物理化学性质、毒理学和生态毒理学特性的测试报告或者资料，以及有关测试机构的资质证明。生态毒理学特性测试报告，必须包括在中国境内用中国的供试生物按照相关标准的规定完成的测试数据。
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Article 11 (Quantity Grades of Regular Notification) A regular notification shall follow the principle of “the higher the quantity grade of notification, the stricter the requirements for test data”. The notifier shall, according to the guide for notification and registration of new chemical substances formulated by the Ministry of Environmental Protection, provide corresponding test data or materials.
The regular notification is classified into four grades in an ascending sequence as follows according to the notified quantity of new chemical substances:
| | 第十一条 【常规申报数量级别】常规申报遵循“申报数量级别越高、测试数据要求越高”的原则。申报人应当按照环境保护部制定的新化学物质申报登记指南，提供相应的测试数据或者资料。
依据新化学物质申报数量，常规申报从低到高分为下列四个级别：
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(1) Grade 1: the new chemical substance produced or imported is more than 1 metric ton but less than 10 metric tons per annum;
| | （一）一级为年生产量或者进口量1吨以上不满10吨的；
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(2) Grade 2: the new chemical substance produced or imported is more than 10 metric tons but less than 100 metric tons per annum;
| | （二）二级为年生产量或者进口量10吨以上不满100吨的；
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(3) Grade 3: the new chemical substance produced or imported is more than 100 metric tons but less than 1,000 metric tons per annum; and
| | （三）三级为年生产量或者进口量100吨以上不满1000吨的；
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(4) Grade 4: the new chemical substance produced or imported is more than 1,000 metric tons per annum.
| | （四）四级为年生产量或者进口量1000吨以上的。
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Article 12 (Basic Circumstances for Simplified Notification) Where a new chemical substance produced or imported is less than 1 metric ton per annum, the producer or importer shall make a simplified notification to the Registration Center prior to production or import.
To make a simplified notification, the following materials shall be submitted:
| | 第十二条 【简易申报基本情形】新化学物质年生产量或者进口量不满1吨的，应当在生产或者进口前，向登记中心办理简易申报。
办理简易申报，应当提交下列材料：
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(1) a simplified notification form for the new chemical substance; and
| | （一）新化学物质简易申报表；
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(2) a report on eco-toxicological testing conducted on Chinese test species within the territory of China.
| | （二）在中国境内用中国的供试生物完成的生态毒理学特性测试报告。
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Article 13 (Special Circumstances for Simplified Notification) Where a new chemical substance produced or imported falls under any of the following circumstances, a simplified notification shall be made:
| | 第十三条 【简易申报特殊情形】生产或者进口的新化学物质有下列特殊情形之一的，应当办理简易申报：
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(1) the new chemical substance is used as an intermediate or only for export with an annual production or import volume of less than 1 metric ton;
| | （一）用作中间体或者仅供出口，年生产量或者进口量不满1吨的；
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(2) the new chemical substance is used for the purpose of scientific research with an annual production or import volume of more than 0.1 metric ton but less than 1 metric ton;
| | （二）以科学研究为目的，年生产量或者进口量0.1吨以上不满1吨的；
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(3) the new chemical substance is a polymer with a monomer concentration less than 2% or a low concern polymer; or
| | （三）新化学物质单体含量低于2％的聚合物或者属于低关注聚合物的；
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(4) the new chemical substance is used for purposes of technics and product research and development with an annual production or import volume of less than 10 metric tons over a period of not more than two years.
To make a simplified notification for special circumstances, a simplified notification form for new chemical substance and the certification materials in line with the circumstances shall be submitted.
| | （四）以工艺和产品研究开发为目的，年生产量或者进口量不满10吨，且不超过二年的。
办理特殊情形简易申报，应当提交新化学物质简易申报表以及符合相应情形的证明材料。
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Article 14 (Requirements for Filing Notification) Under any of the following circumstances, a producer or importer shall, prior to production or import, submit a scientific research filing form for new chemical substances to the Registration Center to handle the scientific research filing notification:
| | 第十四条 【备案申报要求】有下列情形之一的，应当在生产或者进口前，向登记中心提交新化学物质科学研究备案表，办理科学研究备案申报：
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(1) the new chemical substance is used for the purpose of scientific research with an annual production or import volume of less than 0.1 metric ton; or
| | （一）以科学研究为目的，新化学物质年生产量或者进口量不满0.1吨的；
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(2) importing test samples of new chemical substances in order to conduct tests of eco-toxicological properties of new chemical substances on Chinese test species within the territory of China.
| | （二）为了在中国境内用中国的供试生物进行新化学物质生态毒理学特性测试而进口新化学物质测试样品的。
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Article 15 (Serial, Joint and Repeated Notifications) When making a regular notification, under any of the following circumstances, the notifier may go through the formalities for notification according to the following provisions:
| | 第十五条 【系列申报、联合申报、重复申报】办理常规申报，有下列情形之一的，可以按下列规定办理申报手续：
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(1) With respect to several new chemical substances with similar molecular structures, identical or similar uses, or similar test data, the same notifier may propose a serial notification of new chemical substances;
| | （一）同一申报人对分子结构相似、用途相同或者相近、测试数据相近的多个新化学物质，可以提出新化学物质系列申报；
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(2) Where two or more notifiers make notifications of the same new chemical substance simultaneously, and submit notification materials jointly, they may make a joint notification of the new chemical substance; or
| | （二）两个以上申报人同时申报相同新化学物质，共同提交申报材料的，可以提出新化学物质联合申报；
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(3) Where two or more notifiers make notifications for the same new chemical substance successively, and the latter notifier uses the test data of the former notifier upon approval thereof, it may submit a repeated notification of new chemical substance. The sharing method of the cost of data testing shall be negotiated by the notifiers themselves.
| | （三）两个以上申报人先后申报相同新化学物质，后申报人征得前申报人同意后使用前申报人的测试数据的，可以提出新化学物质重复申报。数据的测试费用分担方法，由申报人自行商定。
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Article 16 (Qualification of Notifiers) The notifier or agent thereof of a new chemical substance shall be an institution registered in China.
Those submitting notifications of new chemical substances not for the first time must not have a bad record of administrative punishment for violation of the provisions on environmental management of new chemical substances in recent three years.
| | 第十六条 【申报人资格】新化学物质申报人或者其代理人，应当是中国境内注册机构。
非首次进行新化学物质申报的，近三年内不得有因违反新化学物质环境管理规定而被行政处罚的不良记录。
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Article 17 (Truthful Reporting) A notifier shall, when going through the formalities for notification of a new chemical substance, truthfully submit all known information regarding hazardous properties and environmental risks of the new chemical substance.
| | 第十七条 【如实报告】申报人在办理新化学物质申报手续时，应当如实提交新化学物质危害特性和环境风险的全部已知信息。
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Article 18 (Disclosure of Environmental Information) Where a notifier makes a request for keeping confidential any business secret or technical secret involved in the notification materials it submits, it shall indicate this request in the notification materials.
．．．．．． | | 第十八条 【环境信息公开】申报人对所提交的申报材料中涉及商业秘密或者技术秘密要求保密的，应当在申报材料中注明。
对涉及危害人体健康和环境安全的信息，不得要求保密。
申报人对要求保密的内容予以公开时，应当书面告知登记中心。
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